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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007786
Receipt No. R000009176
Scientific Title "Effect examination of infliximab to the effect insufficient example and the example of effect decrease of the 1st TNF inhibitor in rheumatoid arthritis "
Date of disclosure of the study information 2012/04/19
Last modified on 2016/04/19

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Basic information
Public title "Effect examination of infliximab to the effect insufficient example and the example of effect decrease of the 1st TNF inhibitor in rheumatoid arthritis
"
Acronym Effect examination of infliximab to an anti-TNF invalid example
Scientific Title "Effect examination of infliximab to the effect insufficient example and the example of effect decrease of the 1st TNF inhibitor in rheumatoid arthritis
"
Scientific Title:Acronym Effect examination of infliximab to an anti-TNF invalid example
Region
Japan

Condition
Condition Rheumatoid Arthritis
Classification by specialty
Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Other TNF inhibitor are prescribed for the patient as the 1st selection, IFX is prescribed for the patient to effect insufficiency or the case which carried out effect decrease, and a follow-up survey of the validity is conducted.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes the remission rate of 1-2years after(DAS28(4)-CRP<2.3 or DAS28(4)-ESR<2.6 or SDAI<3.3 or CDAI<2.8)
Key secondary outcomes the low disease activity maintenance rate of 1-2 years after (DAS28(4)-ESR<3.2 or SDAI<11 or CDAI<10
the low disease activity maintenance rate of 1-2 years after (DAS28(4)-ESR<3.2 or SDAI<11 or CDAI<10

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 infliximab plus methotrexate
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria The patient whom is prescribing TNF inhibitors other than infliximab for the patient, and the disease activity (DAS28(4)-ESR >3.2, SDAI>11, or CDAI>10) more than the degree of middle class is maintaining over 12 or more weeks
Key exclusion criteria "1) The patient who is having infliximab medical treatment already experienced
2) The patient who cannot prescribe a methotrexate tablet for the patient
3) The patient who is experienced in TNF inhibitors as for more than 2 agent
4) In addition, the patient who judged that a research doctor was unsuitable "
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Amano
Organization Saitama Medical Center. Saitama Medical University
Division name Division of Rheumatology and Clinical Immunology
Zip code
Address 1981 Kamoda, Kawagoe-shi, SAITAMA
TEL 0492283859
Email amanokoi@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koichi Amano
Organization Saitama Medical Center. Saitama Medical University
Division name Department of Rheumatology & Clinical Immunology
Zip code
Address 1981 Kamoda, Kawagoe-shi, SAITAMA
TEL 0492283859
Homepage URL
Email amanokoi@saitama-med.ac.jp

Sponsor
Institute Saitama Medical Center. Saitama Medical University
Institute
Department

Funding Source
Organization Saitama Medical Center, Saitama Medical Universitity
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2012 Year 04 Month 19 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2012 Year 04 Month 15 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 04 Month 30 Day
Date trial data considered complete
2018 Year 05 Month 31 Day
Date analysis concluded
2018 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date
2012 Year 04 Month 19 Day
Last modified on
2016 Year 04 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009176

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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